MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC GUM TECH GUM HEALTH COMP 1CT; MANUAL TOOTHBRUSH

Model Number	525TPA1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Vomiting (2144); Sore Throat (2396); Choking (2464)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer used brush and bristles came out in their mouth causing them to choke and vomit.Their partner helped them as bristles got caught in their mouth and helped her rinse her mouth.Customer visited doctor due to having a very irritated throat and have been prescribed a benzydamine mouth wash for the pain and inflammation.

• Brand Name: GUM TECH GUM HEALTH COMP 1CT
• Common Device Name: MANUAL TOOTHBRUSH
• Manufacturer (Section D): SUNSTAR AMERICAS, INC; 301 e. central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR INC; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: priya bhatia ; 301 e. central road; schaumburg, IL 60195 ; 8477944331
• MDR Report Key: 23659776
• Report Number: 1413787-2025-00244
• Device Sequence Number: 21363202
• Product Code: EFW
• UDI-Device Identifier: 00070942008112
• UDI-Public: 00070942008112
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 525TPA1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/26/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown